Dec 23 (Reuters) – The U.S. Food and Drug Administration’s approval of an oral version of Novo Nordisk’s weight-loss drug Wegovy could potentially expand access to millions of patients and give the Danish company a much-needed fillip in the red-hot market.
The first GLP-1 pill specifically for obesity, also branded as Wegovy, is a 25-mg oral formulation of semaglutide, the active ingredient in the blockbuster injectable version.
Here’s what we know about this development:
HOW DOES THE PILL COMPARE TO INJECTABLE WEGOVY?
A 64-week, late-stage study showed participants who took the 25 mg of oral semaglutide once daily lost an average of 16.6% of their body weight, compared with 2.7% for those on a placebo.
The injectable version of Wegovy won FDA approval in 2021 after a late-stage trial showed the drug produced an average weight loss of 14.9% at 68 weeks.
Semaglutide belongs to the popular GLP-1 class of drugs driving what analysts expect will become a $150 billion-a-year global obesity market by the next decade.
Oral weight-loss drugs are not expected to fully replace injectables, but analysts estimate pills could capture around one-fifth share of the market by 2030.
WHAT DOES IT MEAN FOR PATIENTS?
Novo says the pill can address injection hesitancy and expand access to the wildly popular glucagon-like peptide-1 receptor agonists, also known as GLP-1s.
Pills could also be a favorable treatment option for those favoring a simple daily dosing, or those patients with less severe obesity.
Potential Medicare coverage later in 2026 could also be a big draw for the pill.
WHAT DOES IT MEAN FOR NOVO?
The approval is a major win for Novo after a rocky year marked by sliding share price and slowing sales of injectable Wegovy in the U.S. amid intense competition from Eli Lilly and pressure from cheaper compounded versions.
It gives Novo a first-mover advantage over Lilly’s orforglipron, a rival GLP-1 oral therapy expected to gain U.S. approval early next year.
Leaders at the FDA have pressed internally for reviewers to speed up evaluation of Lilly’s pill, after the company pushed for a faster timeline, Reuters reported earlier this month.
Novo had squandered its first-to-market advantage with the injectable Wegovy, struggling with supply issues amid surging demand that allowed Lilly to surge ahead with rival Zepbound.
Currently, Zepbound outpaces Wegovy in prescriptions, helped by superior efficacy, a strategic focus on consistent supply and broad consumer access through partnerships with telehealth and digital platforms, helping Lilly become the first drugmaker to hit the $1 trillion valuation.
HOW DO NOVO’S AND LILLY’S PILLS COMPARE?
The Wegovy pill led to an average weight loss of 16.6% in patients during late-stage studies at the end of 64 weeks. Lilly’s experimental pill has shown to help patients lose 12.4% of their body weight at the end of 72 weeks.
Novo’s pill needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking or using any other oral medication. Lilly’s orforglipron can be consumed at any time of the day, making it a more convenient option.
Lilly’s pill is a “small molecule,” making it easier to manufacture in traditional factories, compared with the Wegovy pill, which is a peptide and requires complex biological fermentation.
WHAT ABOUT PRICING?
Analysts and investors expect the oral weight-loss drugs to be priced on par with their injectable versions in a departure from the usual practice of charging more for new medicines.
Novo did not disclose a U.S. list price for the pill.
U.S. list prices for the injectables are about $1,000 per month or more. Both companies have reduced prices of their injectables for customers paying in cash rather than using health insurance.
Under a deal with U.S. President Donald Trump, Novo and Lilly have agreed to offer starter doses of their weight‑loss pills at $149 per month to the government for its Medicare and Medicaid enrollees and to cash payers via the White House’s new direct-to-consumer TrumpRx site.
(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila)
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